510(k) Report

Devices descending from K160441

2 later devices reach Identic and KromaFaze Alginate Dental Impression Materials through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K253501Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set -…Vigodent Indústria E Comercio Ltda20250—
+1K160097Image Fast Set, Image Regular SetSybron Dental Specialties20161—